Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis
Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis
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DOI：
10.1002/art.23427
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发表时间：
2008-05-01
影响因子：
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通讯作者：
Giannini, Edward H.
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文献类型：
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作者：
Lovell, Daniel J.;Reiff, Andreas;Giannini, Edward H.
客观的。旨在评估多关节型幼年类风湿性关节炎 (JRA) 患者长达 8 年的依那西普治疗的安全性和有效性。方法。之前参加过依那西普随机对照试验 (RCT) 的 JRA 患者有资格在长期开放标签扩展 (OLE) 试验中接受依那西普治疗。安全终点包括严重不良事件 (SAE)、医学上重要的感染 (MII) 和死亡的发生率。疗效终点包括美国风湿病学会 (ACR) Pediatric 30 (Pedi 30)、Pedi 50、Pedi 70、Pedi 90 和 Pedi 100 改善标准。结果。在最初参加 RCT 的 69 名患者中，58 名 (84%) 参加了 OLE，总共 318 患者年的依那西普暴露。 58名患者中共有42名患者（72%）进入持续依那西普治疗的第四年，26名患者（45%）进入第八年。 16 名患者（占进入 RCT 患者的 23%）报告了 39 起 SAE。 SAE 的总体发生率（每位患者年 0.12 次）并未随着长期服用依那西普而增加。 MII 发生率（每患者年 0.03 例）仍然很低；据报道，使用依那西普 5 年以上的患者出现了 1 例新的 MII。没有结核病、机会性感染、恶性肿瘤、淋巴瘤、狼疮、脱髓鞘疾病或死亡病例的报告。根据 8 年数据（11 人中的 11 人），100% 的患者实现了 ACR Pedi 70 缓解或更高，根据最后一次观察的结转数据，61% 的患者（46 人中的 28 人）实现了 ACR Pedi 70 缓解或更高。 1结论。这些数据表明，依那西普治疗的可接受的安全性在该 JRA 患者群体中可以维持长达 8 年。 JRA 体征和症状的改善也可维持长达 8 年。
Objective. To evaluate the safety and efficacy of up to 8 years of etanercept treatment in patients with polyarticular-course juvenile rheumatoid arthritis (JRA).Methods. Patients with JRA who previously participated in a randomized controlled trial (RCT) of etanercept were eligible to receive etanercept in a long-term open-label extension (OLE) trial. Safety end points included the incidences of serious adverse events (SAEs), medically important infections (MIIs), and death. Efficacy end points included the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30), Pedi 50, Pedi 70, Pedi 90, and Pedi 100 criteria for improvement.Results. Of the 69 patients originally enrolled in the RCT, 58 (84%) participated in the OLE, for a total of 318 patient-years of etanercept exposure. A total of 42 of the 58 patients (72%) entered the fourth year of continuous etanercept treatment, and 26 patients (45%) entered the eighth year. Sixteen patients (23% of those entering the RCT) reported 39 SAEs. The overall rate of SAEs (0.12 per patient-year) did not increase with long-term exposure to etanercept. The rate of MIIs (0.03 per patient-year) remained low; 1 new MII was reported in patients with >= 5 years of etanercept exposure. No cases of tuberculosis, opportunistic infections, malignancies, lymphomas, lupus, demyelinating disorders, or deaths were reported. An ACR Pedi 70 response or higher was achieved by 100% of patients with 8 years of data (11 of 11) and by 61% of patients according to the last observation carried forward data (28 of 46). 1Conclusion. These data suggest that the acceptable safety profile of etanercept therapy is maintained for up to 8 years in this population of JRA patients. Improvements in the signs and symptoms of JRA were also maintained for up to 8 years.